ZAP-X Radiosurgery System — Class II medical device recall Z-1742-2022
Ongoing recall by Zap Surgical Systems, reported 2022-09-21, distributed nationwide. Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees)
| Recall number | Z-1742-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zap Surgical Systems, San Carlos, CA, United States |
| Recall initiated | 2022-07-05 |
| Classified | 2022-09-14 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860183001504 |
| Serial numbers | ZUC17152, ZUC17153, ZUC18155, ZUC20156, ZUC20157, ZUC20158, ZUC21161, ZUC21162 |
Product
ZAP-X Radiosurgery System
Reason for recall
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1742-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.